ByHeart Baby Formula Recall

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Families File Lawsuits After Infants Hospitalized from Alleged ByHeart Formula Contamination

Pittman, Dutton, Hellums, Bradley & Mann, P.C. is investigating lawsuits filed by parents of infants who were hospitalized after consuming ByHeart baby formula that has since been recalled nationwide following an outbreak of infantile botulism.

Multiple families across the United States have come forward alleging that the ByHeart Whole Nutrition Infant Formula caused severe illness in their babies—some of whom required emergency hospitalization and intensive medical treatment.

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Families Report Severe, Life-Threatening Illnesses

In one case, the parents of a four-month-old infant in Flagstaff, Arizona, reported that their daughter became unresponsive and had to be airlifted to a children’s hospital, where she remained for several weeks under specialized care.

Another family from Richmond, Kentucky, stated that their baby developed sudden symptoms consistent with infantile botulism, including muscle weakness and difficulty feeding. The infant was admitted to the hospital and received an emergency dose of BabyBIG, the only available treatment for the rare illness in infants.

Both children have since been discharged and are recovering, but their parents describe the experience as “terrifying” and “unimaginable.”

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Allegations Against ByHeart

The lawsuits, filed in federal courts in multiple states, allege that ByHeart, Inc., the New York-based manufacturer of the recalled formula, sold a defective and unsafe product and failed to properly test or monitor its safety before distribution.

Families claim that they purchased ByHeart’s formula believing it was a safe, organic, and “clean” alternative to traditional baby formula. Instead, they allege, it was contaminated with Clostridium botulinum, a dangerous bacteria that produces the neurotoxin responsible for botulism.

The suits seek compensation for medical bills, emotional distress, and other losses related to their children’s injuries.

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The Nationwide ByHeart Recall

According to federal health officials, the outbreak began in August 2025, and at least 15 infants across a dozen states have been diagnosed with infantile botulism linked to the formula. ByHeart has since recalled all batches of its formula products, totaling more than 200,000 cans per month.

Testing by California health authorities reportedly confirmed that an open can of ByHeart formula fed to a sick infant contained the bacteria responsible for the illness. The company has stated it is cooperating with ongoing investigations and is “focused on ensuring families are informed about the recall.”

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What Parents Should Know

Infantile botulism is a serious and potentially fatal illness that affects babies under one year old. Early symptoms can include:

• Weakness or floppiness
• Poor feeding or difficulty swallowing
• Constipation
• Loss of head control
• Shallow breathing

Immediate medical attention is critical. The only available treatment, BabyBIG, is an intravenous immune globulin therapy derived from the plasma of vaccinated donors.

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Holding Manufacturers Accountable

Manufacturers of infant formula have a legal duty to ensure product safety, particularly for vulnerable populations such as newborns and infants. When contaminated or defective products reach the market, families have the right to seek justice and financial compensation.

The attorneys at Pittman, Dutton, Hellums, Bradley & Mann, P.C. have decades of experience representing families harmed by unsafe consumer and medical products. Our firm is actively reviewing claims related to the ByHeart formula recall and stands ready to help affected parents pursue accountability and recovery.

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Contact Us for a Free Case Review

If your child consumed ByHeart baby formula and suffered illness or hospitalization, contact our legal team today to discuss your potential claim.

Call (205) 322-8880 or fill out our secure free case evaluation form to learn about your rights. Your family deserves answers — and justice.

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